CN102626538A - Sleep detection-based integrated closed loop deep brain stimulator - Google Patents
Sleep detection-based integrated closed loop deep brain stimulator Download PDFInfo
- Publication number
- CN102626538A CN102626538A CN2012100977188A CN201210097718A CN102626538A CN 102626538 A CN102626538 A CN 102626538A CN 2012100977188 A CN2012100977188 A CN 2012100977188A CN 201210097718 A CN201210097718 A CN 201210097718A CN 102626538 A CN102626538 A CN 102626538A
- Authority
- CN
- China
- Prior art keywords
- sleep
- awakening
- closed loop
- human body
- patient
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
Images
Abstract
The invention provides a sleep detection-based integrated closed loop deep brain stimulator. The sleep detection-based integrated closed loop deep brain stimulator has a real-time sleep detection function, is capable of identifying the sleep or awake state of a patient and is capable of automatically adjustably outputting parameters of electrical stimulation in real time according to different states of the patient. When the patient is sleeping, a pulse generator automatically stops outputting the electrical stimulation or weakening the strength of the electrical stimulation output, and when the patient is awake, a normal operation mode of the pulse generator is recovered. On one hand, the system power consumption of the deep brain stimulator is favorably reduced, and thereby, the service life of the deep brain stimulator is prolonged, and on the other hand, the sleep detection-based integrated closed loop deep brain stimulator is favorable for reducing the harmful effects of the continuous high-frequency electrical simulation to the patient.
Description
Technical field
The present invention relates to a kind of closed loop control method that is used for brain depth stimulator, is a kind of integrated form closed loop brain depth stimulator of adjusting stimulus parameter through identification sleep and awakening automatically, in real time.
Background technology
Implantable medical device has become the patient's of the hardship that receives nerve or mental sickness deeply critical treatment device.The technical progress in nerve stimulation field makes the dark tool development prospect of implantable medical device.Implantable medical device comprises brain depth stimulator (the deep brain stimulator of dyskinetic diseases such as treatment parkinson disease, epilepsy, muscular tension be not normal; DBS); The SCS device of treatment pain (spinal cord stimulator, SCS), treatment epilepsy and depressed vagus nerve stimulator (vagus nerve stimulator; VNS), or the like.
Implantable medical device is treated nerve or mental sickness through the target spot nerve is applied electricity irritation, generally comprises pulse generator, extension lead and stimulating electrode etc.
The brain depth stimulator of clinical practice all belongs to the open loop stimulating system in the world now, promptly can't adjust stimulus parameter automatically according to patient's different demands, can't realize closed loop control.
According to the discovery of clinical research, dyskinesia property patients' such as parkinson disease symptom can be alleviated and even eliminated between sleep period, therefore in patient's sleep procedure, closes pulse generator or reduces intensity of electric stimulus, can the appreciable impact curative effect.
Continue stimulation between sleep period and can cause two problems.The first, the open loop that continues high-frequency electrical stimulation stimulates makes pulse generator be in lasting mode of operation, continues the consuming cells electric weight, when electric weight exhausts, need change battery through operation.For example, there is 4,000,000 Parkinsonian in the whole world at present, and patient's number of China is greatly about about 2,000,000.Treat Parkinsonian needs of patients about 200,000 RMB of cost on device with brain depth stimulator, and the battery of brain depth stimulator can be worked generally 5 years, changed pulse generator when the time comes and will spend about 14～150,000 RMB once more.The medical expense influence for the patient of the sound developed country of medical security of changing the required great number of battery of performing an operation still, for the patient of the not well established developing country of medical security, but is a disaster not quite! The second, nerve nucleus and peripheral nerve loop close relation that brain depth stimulator stimulates, lasting high-frequency electrical stimulation is disturbed normal neural loop to a certain extent, causes the patient to produce harmful effect at aspects such as cognition, behavior, psychology.The problems referred to above make that the demand of development closed loop brain depth stimulator is more urgent.
Therefore, between sleep period, close stimulator or reduce stimulus intensity and have important clinical value.Mainly be manual adjustment at present clinically or close stimulator.The doctor can regulate stimulus parameter or switching pulse generator through vitro program controlled instrument, but obviously can't daily use.The patient can use the magnet contactor pulse generator, perhaps use patient's controller switches pulse generator, in the scope that the doctor authorizes adjusting parameter, but the patient must operate when clear-headed, can't combine with sleeping.
The method that detects patient's sleep has a lot, but most of or can't realize real-time sleep detection, or is unfavorable for developing the closed loop brain depth stimulator of integrated form.Be several kinds of existing sleep detection methods below.
Close pulse generator in the set time of every day section.This method can not be called strict detection patient's sleep, but a kind of artificial definition patient's " sleep " method.For example; Brain depth stimulator
series that U.S. Medtronic Inc. (Medtronic Inc) produces possesses the function of a day circulating working mode (day cycling feature).Though it circulating working mode can make pulse generator close electricity irritation output in the set time of every day section at (for example in evening to point in mornings 8) at 10, concerning the elasticity of demand patient of the length of one's sleep, seems not intelligent.
The EEG signals that obtain human body detect sleep.According to the sleep stage standard that Rechtschaffen and Kales proposed in nineteen sixty-eight, detecting indexs such as brain electricity, myoelectricity, an electricity is the golden standard of sleep study.For example, patent CN201120043642.1 mentions through detecting eeg signal and realizes external sleep detection, and this method needs patient wear that the headgear of scalp electrode is housed, and has increased the operating body burden of sleep characteristics harvester outward.Therefore, detect the realization that sleep has restricted the integrated form brain depth stimulator through EEG signals.
Obtain the moving signal detection sleep of body of human body.For example, patent CN200780040003.6 proposition utilization is laid on pad and is moved signal by the body that following pressure receptor obtains the person to go to bed, judges person to go to bed's sleep or wakefulness.Though this scheme has realized basic sleep/awakening and has detected that the pad that uses in the scheme is unfavorable for realizing integrated closed loop brain depth stimulator.
Therefore, in conjunction with effective closed loop control mechanism, might realize the closed loop brain depth stimulator of integrated form through the moving signal of the body of human body.But existing patent does not all provide the scheme that realizes " integrated form " and " closed loop control " simultaneously.For example, patent WO2006033039-A1 proposes through obtaining the acceleration signal at a plurality of positions such as Parkinsonian's wrist, ankle, according to detected patient's the symptom of trembling, realizes the automatic control of brain depth stimulator.Because this scheme need be carried extra sensing device at a plurality of positions of patient body; And the acceleration information that a plurality of pick offs sense need be transferred to controller by wireless communication technology; Therefore, the said requirement that can not reach the integrated form device of this patent.Again for example, patent US2011082522-A1 has proposed a kind of spinal nerves stimulation protocol of regulating stimulus parameter according to the residing different attitudes of human body.The spinal nerves stimulation is used to treat pains and other diseases.Because the stimulating electrode of spinal nerves stimulator is near spinal column, so when human body was in different attitudes, the relative distance of stimulating electrode and spinal column changed, nonadjustable stimulus parameter can't satisfy curative effect.So this scheme utilization is integrated in the moving signal of body of the acceleration transducer human body in the pulse generator, thereby obtain the residing attitude such as stand, couch, lie on the back of human body, regulate stimulus parameter, realize controlled nerve stimulation according to different attitudes.This scheme is more suitable for the SCS device of treatment pain, but but is not suitable for the brain depth stimulator of diseases such as treatment parkinson disease, epilepsy.Because the residing attitude of patient does not influence the latter's curative effect.
Summary of the invention
To the problems referred to above, the objective of the invention is to realize a kind of integrated form closed loop brain depth stimulator based on sleep detection.This device can be realized " integrated " and " closed loop control " two performances simultaneously.
This device has the function of the moving signal of body of measuring human body, has according to the function of the moving signal in real time identification of body sleep with awakening, has the function of adjusting the treatment operational factor according to the result of sleep detection automatically.The present invention is based on following technical scheme realizes.
A kind of implantable medical device comprises sleep detection module and closed loop control module, it is characterized in that,
Said sleep detection module can be measured the feedback signal of human body, and said feedback signal is carried out pretreatment;
Said closed loop control module can and be awakened according to said feedback signal Real time identification sleep, and adjusts the treatment operational factor to said human body according to the result of said Real time identification.
Preferably, said sleep detection module comprises sensing portion and Signal Pretreatment portion, wherein:
Said sensing portion is used for gathering in real time the feedback signal of human body;
Said Signal Pretreatment portion is connected with said sensing portion, is used for receiving in real time the feedback signal of human body, and said feedback signal is done pretreatment.
Preferably, said closed loop control module comprises:
Sleep/awakening identification part can be according to said feedback signal Real time identification sleep and awakening;
Output is provided with drive division, and the operational factor that said human body is treated can be set, and, be in the sleep or the judged result of wakefulness according to human body, generate the strategy of parameter adjustment automatically, according to said operational factor, output is to the treatment of said human body.
Preferably, when the result of said sleep/awakening identification part identification is sleep state, the treatment of said human body is stopped to export or weakening the intensity of output treatment; When the result of said sleep/awakening identification part identification is wakefulness, the treatment of said human body is set to normal mode of operation.
Preferably, said sleep/awakening identification part is through setting up sleep/awakening Real time identification function, using the detection that the disconnected standard of major punishment realizes sleep in real time or wakefulness.
Preferably, the process of said foundation sleep/awakening recognition function may further comprise the steps,
Signal from the pretreated feedback signal of process Signal Pretreatment portion in the extract real-time human body autonomic activities frequency range,
Obtain the body fatigue resistance of each time slice, the method that characterizes the body fatigue resistance is suc as formula shown in (1)
Wherein, A represents the body fatigue resistance in this time slice, and x (t), y (t), z (t) are respectively the 3-axis acceleration signals after the said processing of sample point process,
Calculate the value of the sleep/awakening Real time identification function of each time slice, this recognition function is suc as formula shown in (2),
D＝P(W
-4A
-4+W
-3A
-3+W
-2A
-2+W
-1A
-1+W
0A
0) (2)
Wherein, P represents scale factor, A
-iRepresent current (i=0) or the body fatigue resistance in i time slice before, W
-iCurrent (i=0) or the weight coefficient of the body fatigue resistance of i time slice are before chosen in representative,
The residing sleep of human body that utilizes the gold method to obtain or wakefulness as standard, through adjusting the value of definite weight parameter, scale factor.Value with the Real time identification function that obtains compares with some or certain several threshold value at last, the preliminary judged result of acquisition sleep/awakening;
The disconnected standard of said major punishment comprises following standard
Major punishment break standard one, to eliminate the erroneous judgement that accidentalia causes disconnected,
Major punishment break standard two, utilize the residing attitude auxiliary examination of human body judged result,
Major punishment break standard three, choose the threshold value of suitable species, status recognition under appropriate sensitivity;
Finally obtain sleep/wakefulness of confirming, comprise awakening, sleep level I, sleep level II ... And deep sleep.
Preferably, said feedback signal is the moving signal of body.
Preferably, the moving signal of said body is the moving signal of body that is positioned at ingrtaclavicular part position, patient front.
Preferably, said body moves the moving signal of body that signal is said implantable medical device implantation position.
Preferably, said closed loop control module can regularly be adjusted said implantable medical device, makes its switching that in a plurality of mode of operations, circulates, and said a plurality of mode of operations comprise:
First mode of operation, wherein said sleep detection module is in opening;
Second mode of operation, wherein said sleep detection module is in closed condition.
According to the described closed loop brain depth stimulator of above technical scheme, the patient need not extra use or wears any harvester or electrode, can realize controlled deep brain stimulation therapy.The sleep detection module that is integrated in the pulse generator has been exempted the burden that the patient uses new equipment to bring, and has realized the seamless connection from the open loop deep brain stimulation to integrated closed loop deep brain stimulation.The sleep detection module that adopts simple, miniature sensing portion to build has the advantage that system complexity is low, integration is strong, has improved the reliability of closed loop brain depth stimulator.
Compared with prior art; The present invention has following advantage: the sleep detection module volume that (1) utilizes miniature sensing portion to build is little, low in energy consumption; Be convenient to develop the closed loop brain depth stimulator of integrated form, need not any additional apparatus of patient wear or increase extra operation; (2) patient who obtains according to the sleep detection module is in the recognition result of sleep or wakefulness, through automatic, the real-time adjustment stimulus parameter of closed loop control module, realizes effective closed loop control; (3) utilize simple checkout equipment to reduce the power consumption of pulse generator, prolonged the service life of brain depth stimulator, and reduced the harmful effect that lasting high-frequency electrical stimulation is brought to the patient.
Description of drawings
Fig. 1 is based on the sketch map of the integrated form closed loop brain depth stimulator of sleep detection.
Fig. 2 is the block diagram of closed loop system of the present invention.
Fig. 3 is the structure chart of pulse generator of the present invention.
Fig. 4 is the circuit design block diagram of pulse generator of the present invention.
Fig. 5 is the signal processing method of Real time identification sleep/awakening of the present invention.
Fig. 6 is the flow chart of first kind of specific embodiments of the closed loop brain depth stimulator based on sleep detection of the present invention.
Fig. 7 is the flow chart of second kind of specific embodiments of the closed loop brain depth stimulator based on sleep detection of the present invention.
The specific embodiment
Be example with integrated form closed loop brain depth stimulator below, technical scheme of the present invention is described based on sleep detection.It will be appreciated by those skilled in the art that concrete example of the present invention can also comprise the implantable medical device of other types, such as cardiac pacemaker, SCS device, vagus nerve stimulator, and implanted drug efflux pump.
This brain depth stimulator comprises pulse generator, extension lead, stimulating electrode etc.Wherein, pulse generator is integrated sleep detection module, closed loop control module etc. need not the function that pulse generator equipment in addition can be realized patient's sleep detection and adjust therapeutic scheme in view of the above.The sleep detection module comprises sensing portion and Signal Pretreatment portion.The closed loop control module comprises that sleep/awakening identification part and output are provided with drive division.
Further; Said sleep detection module is gathered the moving signal of body of the position of human body implantable pulse generator; And, obtaining the state of patient's sleep of living in or awakening through the real-time data processing method of identification sleep with awakening, said closed loop control module is adjusted the treatment operational factor automatically.When the patient was in sleep state, pulse generator stopped to export electricity irritation or weakening the intensity of exporting electricity irritation automatically, and when the patient was in wakefulness, pulse generator recovered normal mode of operation, promptly was operated in the pattern that continues high-frequency electrical stimulation.
Further; The said closed loop control module that combines day circulation pattern; Patient to one type of work and rest rule; Open sleep detection apparatus in the set time of every day section, realized the purpose of the power consumption of further reduction closed loop brain depth stimulator, thereby further prolonged the service time of pulse generator.
Below in conjunction with accompanying drawing the integrated form closed loop brain depth stimulator based on sleep detection of the present invention is done further explain.
Fig. 1 is based on the sketch map of the integrated form closed loop brain depth stimulator of sleep detection.Comprise based on the integrated form closed loop brain depth stimulator of sleep detection and to implant the intravital pulse generator of patient 1, extension lead 2, stimulating electrode 3, and vitro program controlled instrument 4 and Magnet 5.Because the symptom of patient's (for example, the Parkinsonian) in the nighttime sleep process reduces, therefore can be through obtaining the state of patient's nighttime sleep or awakening, adjustment treatment operational factor.When the patient is in sleep state, reduces the intensity of the electricity irritation of exporting or stop to export electricity irritation; When the patient was in wakefulness, the electrical stimulation parameters of output returned to the treatment operational factor under the normal mode of operation.Consistent with the open loop brain depth stimulator is, need be the front that said pulse generator is embedded in the patient is subcutaneous through operation, and the particular core group that stimulating electrode 3 inserts in patient's brains.Compare the open loop brain depth stimulator and attempt to realize the device of controllable type therapy with other; This device is characterised in that, pulse generator is integrated sleep detection module 6 and closed loop control module 7, wherein; Closed loop control module 7 has comprised sleep/awakening identification part 8 and with output drive division 9 has been set; Can be in the different conditions of sleep or awakening according to the patient, automatic, real-time adjustment treatment operational factor realizes the closed loop deep brain stimulation.What pulse generator sent is in the state electricity irritation of ordering parameter automatically of sleeping or awakening with the patient, is transferred to stimulating electrode 3 through planting in subcutaneous extension lead 2, acts on the target spot nerve, suppresses abnormal neural discharge, reaches therapeutic effect.Compare with the technical scheme of present reaction type nerve stimulation; Clear superiority of the present invention is; Can on the basis of open loop deep brain stimulation,, realize closed loop therapy according to the automatic adjustment of treatment operational factor of feedback information not adding any electrode or wearing under the prerequisite of any checkout gear.
Fig. 2 is a closed loop system block diagram of the present invention.Sleep detection module 6 is obtained patient's feedback information, and sleep/awakening identification part 8 obtains the state that the patient is in sleep or awakening according to feedback information, again through output be provided with 9 couples of patients of drive division implement in real time, as required, the treatment of controlled deep brain stimulation.The state of an illness that different therapy operational factors affects the patient is set.When the intensity of electric stimulus reduction that stops to export electricity irritation or output; Be not enough to suppress patient's the state of an illness; In the time of can't keeping the sleep that the patient continues, the intensity of electric stimulus that perhaps ought stop to export electricity irritation or output reduces, and the patient is when getting into wakefulness; Sleep detection module 6 will in time be obtained patient's feedback information, through sleep/awakening identification part 8 and output drive division 9 is set the electricity irritation of exporting is returned to normal mode of operation.The output mode of adjustment electricity irritation is till the state that is in sleep with the patient or awaken matches.Preferably, the moving information of said sleep detection module 6 collection patients' body; And microsensor can be selected by sensing portion, and for example miniature 3-axis acceleration sensor is to obtain the preferred manner of the moving information of body with the advantage of its miniaturization, low-power consumption, high sensitivity etc.
Fig. 3 is the structure chart of pulse generator of the present invention.The pulse generator 1 of said integrated form closed loop brain depth stimulator based on sleep detection structurally mainly comprises sleep detection module 6, closed loop control module 7, power module 10 and communication module 11 etc.Wherein, sleep detection module 6 is made up of sensing portion 12 and Signal Pretreatment portion 13.The microsensor volume of forming said sensing portion 12 is little, low in energy consumption; It is subcutaneous to be implanted to the patient front with pulse generator; The sensitive feedback information that obtains patient front clavicle upper/lower positions; This feedback information is accomplished the conditioning process of necessary signal through the sampling processing circuit, transfers to the identification that sleep/sleep/awaken in awakening identification part 8 afterwards and handles.The function of closed loop control module 7 comprises that real-time generation human body is in the sleep or the recognition result of wakefulness, the therapy operational factor is set and according to the state of sleep quality or awakening, generates the strategy of parameter adjustment automatically.Afterwards,, electricity irritation is outputed to stimulating electrode 3, act on target, reach therapeutic effect through extension lead 2.Communication module 11 is used to realize the signal transmission demand of sleep detection module 6 and external control appliance and closed loop control module 7, comprises IIC/SPI communication module 11-1 and radio-frequency communication module 11-2.Power module 10 provides lasting energy source for above-mentioned each module.
Fig. 4 is the circuit design block diagram of pulse generator of the present invention.Corresponding with the big functional module of four among Fig. 3; Comprise power module 10 (forming) by battery, voltage conditioning module etc.; The sensing portion that forms sleep detection module 6: three axis signal detecting means and Signal Pretreatment portions such as X axis signal detecting means 12-1, Y axis signal detecting means 12-2, Z axis signal detecting means 12-3: A/D modular converter 13-1, denoising module 13-2; The microcontroller 7-1 that forms closed loop control module 7, and the IIC/SPI communication module 11-1 and the radio-frequency communication module 11-2 that form communication module 11.Wherein, the outfan of Signal Pretreatment portion 13 is connected through communication module with the input of microprocessor 7-1, and the input of Signal Pretreatment portion 13 links to each other with sensing portion 12.IIC/SPI communication module 11-1 realizes communicating by letter between microcontroller 7-1 and the sleep detection module 6; Radio-frequency communication module 11-2 realizes that microcontroller 7-1 communicates by letter with the RF bidirectional between the vitro program controlled instrument 4, and vitro program controlled instrument 4 is used for the duty of remote measurement pulse generator 1.In addition, the circuit design block diagram of pulse generator comprises that also output is provided with drive division 9, clock module 15, reed switch 16 etc.Wherein, reed switch 16 switches pulse generator 1 by Magnet 5 controls of outside between Magnet stimulus modelity and automatic stimulus modelity.
Fig. 5 is the signal processing method of Real time identification sleep/awakening of the present invention.The processing procedure of this processing method comprises the contents such as the disconnected standard of major punishment of obtaining sleep/awakening Real time identification function, being directed against first judged result proposition; The entire process process for realize on the sheet, real time signal processing propose maybe, be of value to the closed loop brain depth stimulator of realizing integrated form.
Signal from the feedback information that sleep detection module 6 obtains in the extract real-time human body autonomic activities frequency range, because the frequency of the moving signal of the body of human body autonomic activities is no more than 4Hz, the band limits that extracts is chosen as 0.25Hz～4Hz.
Next step obtains the body fatigue resistance of each time slice.The length of time slice is preferably 30 seconds, and the selection of follow-up for ease recognition function and judgment threshold is with definite.Preferably, the method that characterizes the body fatigue resistance is suc as formula shown in (1).
Wherein, A represents the body fatigue resistance in this time slice, and x (t), y (t), z (t) are respectively that sample point is through the 3-axis acceleration signal behind the said signal processing.Though this expression formula is the universal expression formula that characterizes the body fatigue resistance; But the length of the body fatigue resistance value that obtains and the sensitivity of pick off, precision, signal sampling rate, time slice; And a plurality of factors such as placement location of pick off are relevant, and reasonably choosing each parameter is the key that obtains ideal body fatigue resistance value.
Next step calculates the value of the sleep/awakening Real time identification function of each time slice.This recognition function is suc as formula shown in (2).
D＝P(W
-4A
-4+W
-3A
-3+W
-2A
-2+W
-1A
-1+W
0A
0) (2)
Wherein, P represents scale factor, A
-iRepresent current (i=0) or the body fatigue resistance in i time slice before, W
-iCurrent (i=0) or the weight coefficient of the body fatigue resistance of i time slice are before chosen in representative.
Recognition function (2) is characterised in that, only use when precursor fatigue resistance value and current before body fatigue resistance value, and do not rely on the body fatigue resistance after current, for realizing real-time target detection condition is provided.In order to choose suitable value for the coefficient in the expression formula, need carry out in a large number, test widely, and with standard testing result as standard.
Utilize the gold method of identification sleep/awakening; For example; (polysomnography PSG) can obtain testing result as standard to the sleep analysis monitor appearance, confirms the value of weight parameter, scale factor through adjustment; At last the value of the Real time identification function that obtains and some or certain several threshold value are compared, obtain the judged result of sleeping comparatively accurately/awakening.Body fatigue resistance under human body awakening and the sleep state has notable difference, chooses first kind threshold value and can distinguish " sleep " and " awakening " state.Then, further distinguish the sleep level under " sleep " state according to the difference of body fatigue resistance.Research shows that the height of body fatigue resistance has linear relation, the body fatigue resistance of the body fatigue resistance＞ sleep stage 3,4 of body fatigue resistance＞sleep stage 2 of the body fatigue resistance＞rapid eye movement phase of sleep stage 1 with sleep stage.So, from the switching record of the sleep stage that obtains through the sleep analysis monitor appearance, extract body fatigue resistance when sleep stage switches as second type of threshold value, further judge different sleep level.
Next step, with the first kind threshold value of choosing and second type of threshold ratio, obtain the preliminary judged result of the sleep/awakening of each time slice.Judged result be divided into awakening, sleep level I, sleep level II ..., several kinds of states such as deep sleep.
Next step carries out the disconnected process of major punishment.Because each time slice is shorter, receives the influence of accidentalia, for example, the unconscious state of sitting quietly or repose that stands up under action, the wakefulness under the sleep state all might influence the result who just judges.To the various situation that possibly cause that erroneous judgement is disconnected, stipulate the following major punishment standard of breaking.
Major punishment break standard one, to eliminate the erroneous judgement that accidentalia causes disconnected.When the time slice of the front and back some of the judged result of certain isolated or successive and less state was judged as a certain other state, these isolated or successive and less judged results were negated.
Major punishment break standard two, utilize the residing attitude auxiliary examination of human body judged result.It is disconnected that this standard can be eliminated quiet erroneous judgement upright or that situation such as sit quietly causes.Since in the sleep procedure attitude of human body generally be in lie on the back, prostrate, lie on one's side several kinds, be vertical orientation of human body with quiet maximum difference upright or that sit quietly.Through the polarity of inspection 3-axis acceleration value, perhaps through calculating human body azimuth longitudinally, negative human body is in the sleep state under the quiet upright or attitude of sitting quietly or supports that human body is in the sleep state under the bed posture, and is as the same to the auxiliary examination method of wakefulness.
Major punishment break standard three, choose the threshold value of suitable species, status recognition under appropriate sensitivity.Because the general sleep state that is difficult for awakening through about 20 minutes shallow phase entering of sleeping of human body; After using first kind threshold decision to be " sleep " state; If the judgement of this state has continued 20 minutes; Judgement so can be selected second type of threshold value, the different sleep level in further more sensitive identification " sleep " state.
Finally obtain sleep/wakefulness of confirming: awakening, sleep level I, sleep level II ..., the deep sleep.Detailed sleep/awakening recognition result is that the control strategy that improves the closed loop control module provides condition.On the one hand; Closed loop control module 7 can be adapted to be in the electrical stimulation parameters that the patient accepted under the different conditions according to the recognition result setting; Suppress neuronic undesired discharge with optimum stimulus parameter, the harmful effect that the patient brings is reduced to minimum to lasting high-frequency electrical stimulation; On the other hand, as required, controlled electricity irritation strategy reduced the electric quantity consumption that output is provided with drive division 9, is beneficial to the service time that prolongs power module 10.
Fig. 6 is the flow chart of first kind of specific embodiments of the closed loop brain depth stimulator based on sleep detection of the present invention.This embodiment is based on the simple closed loop deep brain stimulation mode of sleep detection.The 6 round-the-clock unlatchings of sleep detection module obtain the state of the residing sleep of patient/awakening.When the patient was in wakefulness, what output was provided with that drive division 9 continues applied high-frequency electrical stimulation to the target spot nerve, i.e. electricity irritation is in normal mode of operation.When the patient was in sleep state, output was provided with drive division 9 and stops to export electricity irritation or weakening the intensity of exporting electricity irritation.Further, when the patient was in dormant sleep level I, output was provided with drive division 9 corresponding output stimulus intensity grade I; When the patient was in dormant sleep level II, output was provided with drive division 9 corresponding output stimulus intensity grade II; By that analogy.When the patient was in dormant deep sleep, output was provided with drive division 9 and stops to export electricity irritation.The corresponding relation of stimulus intensity grade and sleep level obtains through clinical trial, and purpose is that the intensity of electric stimulus that applies suitable the lowest class reaches best therapeutic effect.
Fig. 7 is the flow chart of second kind of specific embodiments of the closed loop brain depth stimulator based on sleep detection of the present invention.This embodiment is the closed loop deep brain stimulation mode based on sleep detection that has combined day circulation pattern.This embodiment is applicable to the work and rest rule, can keep going to bed every day and WA between one type of patient of change in about two hours.The clock module 15 of pulse generator 1 was calibrated with patient's local time in this embodiment, and carried out subregion round the clock with 8:00 and 22:00 as separation.On the daytime of patient's local time, for example 8:00 is to 22:00, and what output was provided with that drive division 9 continues applies high-frequency electrical stimulation to the target spot nerve, i.e. electricity irritation is in normal mode of operation, and sleep detection module 6 is closed.At the night of patient's local time; For example 22:00 is to 8:00 on daytime next day; Sleep detection module 6 is opened, and output is provided with drive division 9 no longer makes electricity irritation remain on normal mode of operation; But according to the recognition result of 6 pairs of patient's sleep/wakefulnesss of living in of sleep detection module, adjustment treatment operational factor automatically.When the patient was in sleep state, output was provided with the intensity that drive division 9 stops to export electricity irritation or reduces electricity irritation output; When the patient was in wakefulness, output is provided with drive division 9 made electricity irritation return to normal mode of operation.It is similar with first kind of specific embodiments that said output is provided with the mode of operation of time period at night of drive division 9, and promptly according to different sleep/wakefulnesss, different sleep level, the electricity irritation that the output different parameters is provided with is repeated no more.The above-mentioned described sky circulation pattern that is.In conjunction with this embodiment of day circulation pattern, the big advantage of one of which is, has further reduced the energy expenditure of pulse generator 1.
According to a kind of specific embodiments provided by the present invention, a kind of possess round-the-clock sleep detection function, and the embodiment of electricity irritation output function.In suc scheme, the round-the-clock startup of sleep detection module, simultaneously, the operational factor of adjustment treatment in real time.This embodiment has universality to vast patient, uses easier.
According to another kind of specific embodiments provided by the present invention, a kind of control method that has combined the closed loop stimulation of day circulation pattern.This embodiment can be selected the control mode of the closed loop stimulation of more low-power consumption to the patient of certain type of work and rest rule.In this case, the sleep detection module starts in the set time of every day section, and this section period has been contained the time that patient's regularity is gone to bed; In section At All Other Times, the sleep detection module is closed, the probability that the patient who need not to consider such work and rest rule go to bed in the section at this moment.It should be noted that two kinds of embodiments can be according to practical situation, select and change through vitro program controlled instrument.
Aforesaid way is the preferred embodiment of the present invention; For the one of ordinary skilled in the art; On the basis of the integrated form closed loop brain depth stimulator based on sleep detection disclosed by the invention, be easy to expect being applied to various implantable medical devices, and be not limited only to the described system structure of the specific embodiment of the invention; Therefore the mode of front description is just preferred, and does not have restrictive meaning.
Claims (10)
1. an implantable medical device comprises sleep detection module and closed loop control module, it is characterized in that,
Said sleep detection module can be measured the feedback signal of human body, and said feedback signal is carried out pretreatment;
Said closed loop control module can and be awakened according to said feedback signal Real time identification sleep, and adjusts the treatment operational factor to said human body according to the result of said Real time identification.
2. implantable medical device according to claim 1 is characterized in that, said sleep detection module comprises sensing portion and Signal Pretreatment portion, wherein:
Said sensing portion is used for gathering in real time the feedback signal of human body;
Said Signal Pretreatment portion is connected with said sensing portion, is used for receiving in real time the feedback signal of human body, and said feedback signal is done pretreatment.
3. implantable medical device according to claim 1 is characterized in that, said closed loop control module comprises:
Sleep/awakening identification part can be according to said feedback signal Real time identification sleep and awakening;
Output is provided with drive division, and the operational factor that said human body is treated can be set, and, be in the sleep or the judged result of wakefulness according to human body, generate the strategy of parameter adjustment automatically, according to said operational factor, output is to the treatment of said human body.
4. implantable medical device according to claim 3 is characterized in that, when the result of said sleep/awakening identification part identification is sleep state, the treatment of said human body is stopped to export or weakening the intensity of output treatment; When the result of said sleep/awakening identification part identification is wakefulness, the treatment of said human body is set to normal mode of operation.
5. implantable medical device according to claim 3 is characterized in that, said sleep/awakening identification part is through setting up sleep/awakening Real time identification function, using the detection that the disconnected standard of major punishment realizes sleep in real time or wakefulness.
6. implantable medical device according to claim 5 is characterized in that, the process of said foundation sleep/awakening recognition function may further comprise the steps,
Signal from the pretreated feedback signal of process Signal Pretreatment portion in the extract real-time human body autonomic activities frequency range,
Obtain the body fatigue resistance of each time slice, the method that characterizes the body fatigue resistance is suc as formula shown in (1)
Wherein, A represents the body fatigue resistance in this time slice, and x (t), y (t), z (t) are respectively the 3-axis acceleration signals after the said processing of sample point process,
Calculate the value of the sleep/awakening Real time identification function of each time slice, this recognition function is suc as formula shown in (2),
D＝P(W
-4A
-4+W
-3A
-3+W
-2A
-2+W
-1A
-1+W
0A
0) (2)
Wherein, P represents scale factor, A
-iRepresent current (i=0) or the body fatigue resistance in i time slice before, W
-iCurrent (i=0) or the weight coefficient of the body fatigue resistance of i time slice are before chosen in representative,
The residing sleep of human body that utilizes the gold method to obtain or wakefulness as standard, through adjusting the value of definite weight parameter, scale factor.Value with the Real time identification function that obtains compares with some or certain several threshold value at last, the preliminary judged result of acquisition sleep/awakening;
The disconnected standard of said major punishment comprises following standard
Major punishment break standard one, to eliminate the erroneous judgement that accidentalia causes disconnected,
Major punishment break standard two, utilize the residing attitude auxiliary examination of human body judged result,
Major punishment break standard three, choose the threshold value of suitable species, status recognition under appropriate sensitivity;
Finally obtain sleep/wakefulness of confirming, comprise awakening, sleep level I, sleep level II ... And deep sleep.
7. according to the described implantable medical device of one of claim 1-6, it is characterized in that said feedback signal is the moving signal of body.
8. according to the described implantable medical device of one of claim 1-6, it is characterized in that the moving signal of said body is the moving signal of body that is positioned at ingrtaclavicular part position, patient front.
9. according to the described implantable medical device of one of claim 1-6, it is characterized in that the moving signal of body that the moving signal of said body is said implantable medical device implantation position.
10. according to the described implantable medical device of one of claim 1-6, it is characterized in that said closed loop control module can regularly be adjusted said implantable medical device, make its switching that in a plurality of mode of operations, circulates, said a plurality of mode of operations comprise:
First mode of operation, wherein said sleep detection module is in opening;
Second mode of operation, wherein said sleep detection module is in closed condition.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210097718.8A CN102626538B (en) | 2012-03-30 | 2012-03-30 | Sleep detection-based integrated closed loop deep brain stimulator |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210097718.8A CN102626538B (en) | 2012-03-30 | 2012-03-30 | Sleep detection-based integrated closed loop deep brain stimulator |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN102626538A true CN102626538A (en) | 2012-08-08 |
| CN102626538B CN102626538B (en) | 2015-05-13 |
Family
ID=46585042
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201210097718.8A Active CN102626538B (en) | 2012-03-30 | 2012-03-30 | Sleep detection-based integrated closed loop deep brain stimulator |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN102626538B (en) |
Cited By (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103654771A (en) * | 2012-08-29 | 2014-03-26 | 联想(北京)有限公司 | Brain wave detection device and power management method thereof |
| CN103845807A (en) * | 2012-12-07 | 2014-06-11 | 苏州景昱医疗器械有限公司 | Periodic stimulation method and system of implantable nerve stimulator |
| CN103845793A (en) * | 2012-12-07 | 2014-06-11 | 苏州景昱医疗器械有限公司 | Implantable nerve stimulator, system and method for combining multiple sets of stimulus parameters |
| CN104615851A (en) * | 2014-12-31 | 2015-05-13 | 深圳市元征科技股份有限公司 | Sleep monitoring method and terminal |
| CN104850218A (en) * | 2014-02-19 | 2015-08-19 | 联想(北京)有限公司 | Information processing method and wearable equipment |
| WO2015164143A1 (en) * | 2014-04-25 | 2015-10-29 | Medtronic, Inc. | Deep brain stimulation for sleep disorders |
| CN105997004A (en) * | 2016-06-17 | 2016-10-12 | 美的集团股份有限公司 | Sleep reminding method and sleep monitoring device |
| CN106621041A (en) * | 2016-12-21 | 2017-05-10 | 北京品驰医疗设备有限公司 | Configuration system for electronic prescription of vagus nerve stimulator |
| CN108607159A (en) * | 2018-03-21 | 2018-10-02 | 重庆邮电大学 | A kind of DBS system acquiring LFP data |
| CN109078261A (en) * | 2018-04-02 | 2018-12-25 | 郑明德 | Big data sleep therapy bracelet |
| CN109260566A (en) * | 2018-09-12 | 2019-01-25 | 深圳众赢时代科技有限公司 | Enhance sleep technology using shadow casting technique |
| CN109567752A (en) * | 2018-11-19 | 2019-04-05 | 深圳融昕医疗科技有限公司 | Judgment method, device, sleep monitor and the storage medium of sleep wakefulness state |
| CN109568760A (en) * | 2017-09-29 | 2019-04-05 | 中国移动通信有限公司研究院 | Sleep environment adjusting method and system |
| CN112675430A (en) * | 2021-02-03 | 2021-04-20 | 杭州睿笛生物科技有限公司 | Closed-loop control median nerve stimulator and use method thereof |
| CN114461075A (en) * | 2022-02-11 | 2022-05-10 | 清华大学 | Closed-loop self-adaptive computer-computer interface equipment and control method thereof |
| CN115736952A (en) * | 2022-11-17 | 2023-03-07 | 深圳市心流科技有限公司 | Working state control method of sign detection device and terminal equipment |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20110082522A1 (en) * | 2005-12-02 | 2011-04-07 | Medtronic, Inc. | Closed-loop therapy adjustment |
| CN202020792U (en) * | 2011-02-22 | 2011-11-02 | 鼎迈医疗科技(苏州)有限公司 | Reaction type nerve electric stimulation system with external sleep detection device |
| CN102343123A (en) * | 2010-07-29 | 2012-02-08 | 鼎迈医疗科技(苏州)有限公司 | Feedback type nervous electrical stimulation system and feedback control method thereof |
-
2012
- 2012-03-30 CN CN201210097718.8A patent/CN102626538B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20110082522A1 (en) * | 2005-12-02 | 2011-04-07 | Medtronic, Inc. | Closed-loop therapy adjustment |
| CN102343123A (en) * | 2010-07-29 | 2012-02-08 | 鼎迈医疗科技(苏州)有限公司 | Feedback type nervous electrical stimulation system and feedback control method thereof |
| CN202020792U (en) * | 2011-02-22 | 2011-11-02 | 鼎迈医疗科技(苏州)有限公司 | Reaction type nerve electric stimulation system with external sleep detection device |
Cited By (21)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103654771A (en) * | 2012-08-29 | 2014-03-26 | 联想(北京)有限公司 | Brain wave detection device and power management method thereof |
| CN103845807A (en) * | 2012-12-07 | 2014-06-11 | 苏州景昱医疗器械有限公司 | Periodic stimulation method and system of implantable nerve stimulator |
| CN103845793A (en) * | 2012-12-07 | 2014-06-11 | 苏州景昱医疗器械有限公司 | Implantable nerve stimulator, system and method for combining multiple sets of stimulus parameters |
| CN104850218B (en) * | 2014-02-19 | 2018-04-27 | 联想(北京)有限公司 | A kind of information processing method and Wearable |
| CN104850218A (en) * | 2014-02-19 | 2015-08-19 | 联想(北京)有限公司 | Information processing method and wearable equipment |
| WO2015164143A1 (en) * | 2014-04-25 | 2015-10-29 | Medtronic, Inc. | Deep brain stimulation for sleep disorders |
| US9821162B2 (en) | 2014-04-25 | 2017-11-21 | Medtronic, Inc. | Deep brain stimulation for sleep disorders |
| WO2016107217A1 (en) * | 2014-12-31 | 2016-07-07 | 深圳市元征科技股份有限公司 | Sleep monitoring method and terminal |
| CN104615851A (en) * | 2014-12-31 | 2015-05-13 | 深圳市元征科技股份有限公司 | Sleep monitoring method and terminal |
| CN104615851B (en) * | 2014-12-31 | 2019-06-11 | 深圳市元征科技股份有限公司 | A kind of Sleep-Monitoring method and terminal |
| CN105997004A (en) * | 2016-06-17 | 2016-10-12 | 美的集团股份有限公司 | Sleep reminding method and sleep monitoring device |
| CN106621041A (en) * | 2016-12-21 | 2017-05-10 | 北京品驰医疗设备有限公司 | Configuration system for electronic prescription of vagus nerve stimulator |
| CN109568760A (en) * | 2017-09-29 | 2019-04-05 | 中国移动通信有限公司研究院 | Sleep environment adjusting method and system |
| CN108607159A (en) * | 2018-03-21 | 2018-10-02 | 重庆邮电大学 | A kind of DBS system acquiring LFP data |
| CN109078261A (en) * | 2018-04-02 | 2018-12-25 | 郑明德 | Big data sleep therapy bracelet |
| CN109260566A (en) * | 2018-09-12 | 2019-01-25 | 深圳众赢时代科技有限公司 | Enhance sleep technology using shadow casting technique |
| CN109567752A (en) * | 2018-11-19 | 2019-04-05 | 深圳融昕医疗科技有限公司 | Judgment method, device, sleep monitor and the storage medium of sleep wakefulness state |
| CN112675430A (en) * | 2021-02-03 | 2021-04-20 | 杭州睿笛生物科技有限公司 | Closed-loop control median nerve stimulator and use method thereof |
| CN114461075A (en) * | 2022-02-11 | 2022-05-10 | 清华大学 | Closed-loop self-adaptive computer-computer interface equipment and control method thereof |
| CN115736952A (en) * | 2022-11-17 | 2023-03-07 | 深圳市心流科技有限公司 | Working state control method of sign detection device and terminal equipment |
| CN115736952B (en) * | 2022-11-17 | 2023-11-17 | 深圳市心流科技有限公司 | Working state control method of physical sign detection device and terminal equipment |
Also Published As
| Publication number | Publication date |
|---|---|
| CN102626538B (en) | 2015-05-13 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN102626538B (en) | Sleep detection-based integrated closed loop deep brain stimulator | |
| JP5432166B2 (en) | Closed-loop feedback for manipulating stimulation energy in tissue | |
| CN110062643A (en) | High frequency nerve stimulation for the control of pelvis symptom | |
| CN103785105B (en) | A kind of patient controller, implantable nerve stimulating system and feedback regulation method | |
| US11439825B2 (en) | Determining posture state from ECAPs | |
| US11752342B2 (en) | System for neuromodulation | |
| CN110327547A (en) | A kind of lesions located in deep brain system of multichannel thorniness stimulus | |
| US20230233861A1 (en) | Sensing cardiac signals with leads implanted in epidural space | |
| CN202876088U (en) | Patient controller and implantable nerve stimulating system | |
| EP4274656A1 (en) | Determining estimated neural threshold with ecap signals | |
| AU2020428944B2 (en) | Closed loop control in spinal cord stimulation therapy with non-detectable neural responses | |
| US11944819B2 (en) | Analyzing ECAP signals | |
| CN111659005A (en) | Foot drop rehabilitation device based on myoelectric signals | |
| CN117018454A (en) | Automatic frequency intensity adjusting method and system for biofeedback magnetic stimulator | |
| CN106621041A (en) | Configuration system for electronic prescription of vagus nerve stimulator | |
| CN106492347A (en) | A kind of vagus nerve stimulator electronic prescription configuration system of quickly-chargeable | |
| CN106730337A (en) | A kind of vagus nerve stimulator electronic prescription configuration system of quickly-chargeable | |
| US20230364426A1 (en) | Neuromodulation therapy optimization using sleep and activity derived measures | |
| CN117298449B (en) | Closed-loop DBS regulation and control method and system based on wearable equipment | |
| US20230241395A1 (en) | Control of medical device using representative value | |
| US11904170B2 (en) | Patient-learned control of medical device | |
| CN210186244U (en) | Device for desynchronizing neuronal activity | |
| Du et al. | A new EEG recording and electrical stimulation medical device with independent feedback control function | |
| Chiao | Wireless closed-loop stimulation systems for symptom management | |
| WO2023108176A1 (en) | Systems and methods for vagus nerve stimulation with closed-loop monitoring |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant |